CurrentCignaPolicy N/A

Orgovyx (relugolix) — Drug Quantity Management (coverage criteria)

Defines quantity limits, exceptions, and authorization criteria for Orgovyx (relugolix) tablets for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOrgovyx (relugolix) — Drug Quantity Management (coverage criteria)

Policy CodePolicy N/A

Change TypeRevised (quantity limits and one-time override)Clarified

Effective DateN/A

Next Review DateMar 18, 2026

Key ActionRequest a one-time override (30-day duration) for a 360 mg loading dose when therapy was interrupted ≥7 days, documenting clinical justification to approve 32 tablets retail or 92 tablets home delivery.

SourceLink

POLICY UPDATE CHANGES

Override criteria were modified to approve a one-time override for 32 tablets at retail or 92 tablets at home delivery for patients initiating or restarting therapy (≥7-day interruption) who require a 360 mg loading dose on day 1.

Drug quantity limits specified: retail max 30 tablets per Rx; home delivery max 90 tablets per Rx.

Policy Statement was updated to clarify that 'one-time' overrides are provided for 30 days.

30Retail max per Rx

90Home delivery max per Rx

32 / 92One-time override (retail/home)

60 / 180Exception quantities (retail/home)

Coverage Criteria and Exceptions

Exceptions (medically necessary)

Exceptions to the stated quantity limits are considered medically necessary when ALL of the following distinct criteria are met for each exception type.

Exception types

A - Combined P-gp and strong CYP3A inducer: If the patient is taking a combined P-gp inducer AND a strong CYP3A inducer, approve 60 tablets per dispensing at retail or 180 tablets per dispensing at home delivery.
Examples of strong CYP3A inducers include, but are not limited to, apalutamide, carbamazepine, fosphenytoin, phenobarbital, phenytoin, and rifampin.
B - Initiation/restart with loading dose: If the patient is initiating or restarting therapy (>= 7-day interruption) and requires a dose of 360 mg on the first day of therapy, approve a one-time override for 32 tablets at retail or 92 tablets at home delivery.>= 7 days
One-time overrides are provided for 30 days.

Policy Summary

PayerCigna

PolicyOrgovyx (relugolix) — Drug Quantity Management (coverage criteria)

Policy CodePolicy N/A

Change TypeRevised (quantity limits and one-time override)Clarified

Effective DateN/A

Next Review DateMar 18, 2026

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Exceptions to the quantity limits listed in this policy are covered as medically necessary only when the specific criteria described under the "Exceptions to the Quantity Limits" section are met for the individual request. Requests that do not meet all required exception criteria will not be approved as medically necessary.

Any exception to the stated quantity limits that does not meet the listed exception criteria is considered not medically necessary and will be denied.

Coding and Therapy Thresholds

Covered CPT Codesmixed

No codes listed

Therapy interruption threshold (restart definition)

Therapy interruption threshold>= 7 days

ContextIf treatment is interrupted for > 7 days, patients must restart with a 360 mg loading dose on Day 1 then 120 mg QD thereafter.

Related actionOne-time override for loading dose may be approved when restart follows a >= 7-day interruption.

Provider Actions, Documentation, and Authorization

Prior Authorization

Authorization duration and overrides

All approvals are provided for 1 year in duration, unless otherwise noted. One-time overrides are provided for 30 days in duration.

Approvals: standard authorization durations = 1 year.
One-time overrides (short-term exception) = 30 days.

Documentation Required

Required documentation for exceptions

Providers must document the clinical justification when requesting an exception to quantity limits. Include relevant clinical notes, medication history, indication, dosing rationale, prior authorization forms, and any supporting evidence (e.g., chart notes, test results) that demonstrate medical necessity for the exception.

Document indication and diagnosis related to Orgovyx use.
Provide dosing rationale and any recent medication changes or interruptions (e.g., restarting after ≥ 7-day interruption).
Attach prior authorization forms, relevant chart notes, and supporting test results or specialist consultation notes.

Denial Risk

Provider follow-up and denial triggers

If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria below. Denials will occur for claims not accompanied by covered codes or that fail to meet the specified criteria; providers must follow the documented criteria and submit required documentation or request the appropriate one-time override when applicable.

Coverage determination follows the listed clinical criteria when quantity limits are exceeded.
Claims without covered codes or failing to meet criteria will be denied — submit supporting documentation or request override.
Examples of approvable exceptions are provided in the Criteria (e.g., combined P-gp plus strong CYP3A inducers; one-time override for initiation/restart requiring 360 mg on day 1).

Background and Indication

Orgovyx (relugolix) is supplied as 120 mg tablets. Standard dosing includes a 360 mg loading dose on Day 1 followed by 120 mg once daily. The policy establishes quantity limits of Retail: 30 tablets per Rx and Home Delivery: 90 tablets per Rx, with specified exception criteria for situations requiring larger quantities.

Definitions and Key Dosage Terms

360 mg on Day 1 followed by 120 mg daily (loading dose)

Loading dose definition360 mg on Day 1 followed by 120 mg once daily

When requiredRequired when initiating therapy or restarting after an interruption > 7 days.

PurposeAchieve therapeutic suppression when therapy is started or resumed following interruption.

Initial Therapy and Loading Dose Overrides

Loading dose override

Covered when ALL of the following are met for patients initiating or restarting therapy who may require a loading dose.

Loading dose when initiating/restarting: Requires 360 mg on Day 1 then 120 mg daily; if therapy is interrupted >= 7 days, a loading dose is required and a one-time override may be approved.>= 7 days

One-time override quantities: 32 tablets at retail or 92 tablets at home delivery. One-time overrides are provided for 30 days.

Quantity Limits and Exception Quantities

Orgovyx (relugolix) 120 mg tablets — quantity limits

Retail maximum per Rx30 tablets per Rx

Home delivery maximum per Rx90 tablets per Rx

Strength and packagingOrgovyx (relugolix) 120 mg tablets (30 tablets/bottle)

Orgovyx (relugolix) 120 mg tablets — exception for combined P-gp AND strong CYP3A inducer

Exception conditionPatient is taking a combined P-gp inducer AND a strong CYP3A inducer

Retail exception quantityApprove 60 tablets per dispensing at retail

Home delivery exception quantityApprove 180 tablets per dispensing at home delivery

Orgovyx (relugolix) 120 mg tablets — one-time override quantities for loading dose

One-time override purposeTo provide the 360 mg loading dose when initiating or restarting therapy after a >= 7-day interruption

Retail one-time override quantity32 tablets (one-time override)

Home delivery one-time override quantity92 tablets (one-time override)